Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trial

What Was Tested

Researchers studied Somatostatin and Pasireotide in this randomized controlled trial publication.

There are no data from prospective studies focused exclusively on patients with advanced lung and thymic carcinoids.

Who Took Part

According to the abstract, 2 patients were involved.

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus, with radiological progression within 12 months before randomisation, and a WHO performance status of 0-2.

At each centre, the investigator or their designee registered each patient using an interactive voice recognition system into one of the three treatment groups.

How the Study Was Run

The researchers set it up as a randomized, open-label and multicenter study.

The patients were allocated by chance, so the Somatostatin group and the comparison group should start out alike.

Nothing was hidden in this open-label Somatostatin study: the patients and staff both knew the treatment.

Running at several centres spread the Somatostatin study over different clinics and patient groups.

The timeline in the abstract includes 12 months.

Patients were stratified by carcinoid type (typical vs atypical) and line of study treatment (first line vs others).

The primary endpoint was the proportion of patients progression-free at month 9, defined as the proportion of patients with overall lesion assessment at month 9 showing a complete response, partial response, or stable disease according to local Response Evaluation Criteria in Solid Tumors, version 1.1, assessed in the intention-to-treat population.

The trial is registered with ClinicalTrials.gov, number NCT01563354.

The extension phase of the study is ongoing.

What Was Measured

The subject headings attached to it are Antineoplastic Combined Chemotherapy Protocols, Carcinoid Tumor, Disease-Free Survival, Everolimus, Lung Neoplasms, Neoplasm Invasiveness and Neoplasm Staging.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Somatostatin and Pasireotide in 2 patients over 12 months.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2017 (The Lancet. Oncology), a journal based in England.

More context: the Somatostatin compound page and the Pasireotide compound page, all human trials.